Definition of Post-Launch Product R&D Expenses


Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4 clinical trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance), in each case that are (a) specifically attributable to a Adeona Product in the countries of the Territory where such Adeona Product has been launched and (b) approved by both Parties in writing.
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Examples of Post-Launch Product R&D Expenses in a sentence

Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 consist of (a) Cost of Goods Sold, (b) Marketing Expenses, (c) Distribution Expenses, (d) Post-Launch Product R&D Expenses, and (e) Regulatory Expenses (as such terms are defined in Exhibit 1.8).
POST-LAUNCH PRODUCT R&D EXPENSES Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Collaboration Product after the first commercial launch and shall exclude administrative expenses.
All Phase IIIb Costs and Phase IV Costs shall be Post-Launch Product R&D Expenses, which are taken into account in the calculation of Product Profit, except for those Phase IIIb Costs incurred with respect to a Phase IIIb Trial that the Parties mutually agree to include within the scope of Development pursuant to Section 3.2(e).
Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Licensed Product after the first commercial launch and shall exclude administrative expenses and costs that are included within Costs of Goods Sold.